| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2824528 | U | FL | 02/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Rash
Rash
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patients that have developed a skin rash; This non-serious case was reported by a physician via sale...
patients that have developed a skin rash; This non-serious case was reported by a physician via sales rep and described the occurrence of skin rash in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the unspecified number of patients patient received Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced skin rash (Verbatim: patients that have developed a skin rash). The outcome of the skin rash was unknown. The reporter considered the skin rash to be related to Shingrix. The company considered the skin rash to be related to Shingrix. Additional Information: GSK Receipt Date:06-JAN-2025 Physician mentioned that he had patients that have developed a skin rash following a dose of Shingrix.
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| 2824529 | U | 02/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Erythema, Herpes zoster, Pruritus, Vaccination failure
Erythema, Herpes zoster, Pruritus, Vaccination failure
|
Suspected vaccination failure; you can still get it after getting the vaccine I did but it's a...
Suspected vaccination failure; you can still get it after getting the vaccine I did but it's a much weakened version; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included post herpetic neuralgia (Developed Post Herpetic Neuralgia right after the Shingles cleared up), shingles (right after the Shingles cleared up) and pain. Previously administered products included Gabapentin and Codine. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: you can still get it after getting the vaccine I did but it's a much weakened version). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 05-JAN-2025 This case was reported by a patient via interactive digital media. Consumer reported that they got it really bad 4 years ago. Developed Post Herpetic Neuralgia right after the Shingles cleared up and the pain upped a few notches. He /she couldn't stand up straight or hardly move because of it. Internal electric shocks had doubled up for almost a week until they saw a doctor (in person) and he knew what it was and got the patient on Gabapentin. Patient had gone to an urgent care, and they only gave them codine - which was did nothing for the pain. Got the vaccine as soon as possible doctor was recommended for waiting a year and he/she thoroughly recommends getting the shingles vaccine if you've ever had Chickenpox because the virus never goes away. Consumer mentioned that you can still get it after getting the vaccine as he/she did but it's was much weakened version mostly just really itchy and a few red spots in the same area. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the completion of primary vaccination schedule, time to onset of shingles and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
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| 2824530 | U | 02/04/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Feeling abnormal
Feeling abnormal
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felt like hell for a week-bad reaction; This non-serious case was reported by a consumer via interac...
felt like hell for a week-bad reaction; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling abnormal (Verbatim: felt like hell for a week-bad reaction). The outcome of the feeling abnormal was resolved (duration 1 week). It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine. It was unknown if the company considered the feeling abnormal to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 08-JAN-2025 This case was reported by a patient via interactive digital media. The patient reported that the vaccine was a series of 2 shots. The patient had received the 1st dose and felt like hell for a week-bad reaction, so he/she did not get the 2nd shot. But patient further reported that shingles was a way worse hell so he/she probably should have had the 2nd dose.
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| 2824531 | U | 02/04/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Dyspnoea
Dyspnoea
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I'm having more trouble breathing since the shot; This non-serious case was reported by a consu...
I'm having more trouble breathing since the shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of difficulty breathing in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced difficulty breathing (Verbatim: trouble breathing). The outcome of the difficulty breathing was not reported. It was unknown if the reporter considered the difficulty breathing to be related to Arexvy. It was unknown if the company considered the difficulty breathing to be related to Arexvy. Additional Information: GSK Receipt Date: 19-JAN-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she had more trouble breathing since the shot.
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| 2824532 | U | 02/04/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; also had shingles several years later; within a few days, came down w...
Suspected vaccination failure; also had shingles several years later; within a few days, came down with shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: also had shingles several years later) and shingles (Verbatim: within a few days, came down with shingles). The outcome of the vaccination failure, shingles and shingles were not reported. It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 20-JAN-2025 This case was reported by a patient via interactive digital media. Patient reported that he/she received the Shingles shot and within a few days, came down with Shingles. He/she also mentioned that it was horrible, and asked to keep in mind that this was a possibility. Patient also had shingles several years later. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, completion of primary vaccination schedule, time to onset of shingles and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
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| 2824533 | U | 02/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Product use in unapproved indication
Product use in unapproved indication
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unapproved indication; This non-serious case was reported by a consumer via interactive digital medi...
unapproved indication; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug use for unapproved indication in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug use for unapproved indication (Verbatim: unapproved indication). The outcome of the drug use for unapproved indication was unknown. Additional Information: GSK Receipt Date: 24-JAN-2025 This case was reported by a patient via interactive digital media. The reporter reported that patient was glad to had shot when he/she came down with them, which led to Drug use for unapproved indication.
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| 2824535 | M | IL | 02/04/2025 |
DTAP DTAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination, Product administered to patient of inappropria...
Incomplete course of vaccination, Product administered to patient of inappropriate age; Incomplete course of vaccination, Product administered to patient of inappropriate age
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aask for a 8 years old patient that they don't know which vaccine can they give him; patient re...
aask for a 8 years old patient that they don't know which vaccine can they give him; patient received 3 DTaP and last one was at 4 years and 10 months old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 8-year-old male patient who received DTPa (Infanrix) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis. Previously administered products included Infanrix (received 2nd dose on an unknown date) and Infanrix (received 1st dose on an unknown date). On an unknown date, the patient received Infanrix and the 3rd dose of Infanrix. On an unknown date, an unknown time after receiving Infanrix and not applicable after receiving Infanrix, the patient experienced incomplete course of vaccination (Verbatim: aask for a 8 years old patient that they don't know which vaccine can they give him) and inappropriate age at vaccine administration (Verbatim: patient received 3 DTaP and last one was at 4 years and 10 months old). The outcome of the incomplete course of vaccination and inappropriate age at vaccine administration were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 28-NOV-2024 The healthcare professional called to ask for a 8 years old patient that they did not know which vaccine could they give him. They could not give the Dtap, the Kinrix or the Tdap because of his age. The reporter asked which vaccine could be administered. The patient received 3 DTaP and last one was at 4 years and 10 months old which led to inappropriate age at vaccine administration. Till the time of reporting, the patient did not receive booster dose of Infanrix vaccine, which led to incomplete course of vaccination.
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| 2824536 | 69 | F | FL | 02/04/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
|
Injection site pain
Injection site pain
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painful lump in her left deltoid; painful lump in her left deltoid; This non-serious case was report...
painful lump in her left deltoid; painful lump in her left deltoid; This non-serious case was reported by a physician via call center representative and described the occurrence of injection site lump in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 06-DEC-2024, the patient received Arexvy (intramuscular, left deltoid). On 06-DEC-2024, less than a day after receiving Arexvy, the patient experienced injection site lump (Verbatim: painful lump in her left deltoid) and injection site pain (Verbatim: painful lump in her left deltoid). The outcome of the injection site lump and injection site pain were not resolved. It was unknown if the reporter considered the injection site lump and injection site pain to be related to Arexvy. It was unknown if the company considered the injection site lump and injection site pain to be related to Arexvy. Additional Information: GSK Receipt Date: 08-JAN-2025 The patient self-reported this case for herself. Patient reported that she received her Arexvy vaccine and has had a painful lump in her left deltoid that has not resolved.
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| 2824537 | 0.33 | M | WA | 02/04/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
34MF9 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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a patient that received the Kinrix vaccine that was 4 months old; it was the 2nd dose of DTap and IP...
a patient that received the Kinrix vaccine that was 4 months old; it was the 2nd dose of DTap and IPV for the patient; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis. On 27-DEC-2024, the patient received Kinrix. On 27-DEC-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a patient that received the Kinrix vaccine that was 4 months old) and inappropriate schedule of vaccine administered (Verbatim: it was the 2nd dose of DTap and IPV for the patient). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 08-JAN-2025 A patient that received the Kinrix vaccine that was 4 months old, which led to an inappropriate age at vaccine administration. According to reporter, it was the 2nd dose of DTap and IPV for the patient, which led to an inappropriate schedule of vaccine administered. The vaccine administration facility was the same as primary reporter.
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| 2824538 | 18 | F | GA | 02/04/2025 |
MNQ MNQ MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
7GF79 AMVA989A |
Extra dose administered, Interchange of vaccine products, Wrong patient received...
Extra dose administered, Interchange of vaccine products, Wrong patient received product; Extra dose administered, Interchange of vaccine products, Wrong patient received product; Extra dose administered, Interchange of vaccine products, Wrong patient received product
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menveo was given to a patient by mistake; menveo was given to a patient by mistake; had Menactra fir...
menveo was given to a patient by mistake; menveo was given to a patient by mistake; had Menactra first dose and received Menveo second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 7GF79, expiry date 31-DEC-2025) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number AMVA989A) for prophylaxis and Meningococcal vaccine A/C/Y/W conj (dip tox) (Menactra) for prophylaxis. Concomitant products included HPV vaccine VLP rL1 4v (yeast) (Gardasil). On 08-JAN-2025, the patient received the 2nd dose of Menveo. On 27-NOV-2024, the patient received the 1st dose of Menveo. On 01-MAY-2023, the patient received the 1st dose of Menactra. On 27-NOV-2024, not applicable after receiving Menveo and an unknown time after receiving Menveo, the patient experienced interchange of vaccine products (Verbatim: had Menactra first dose and received Menveo second dose). On 08-JAN-2025, the patient experienced extra dose administered (Verbatim: menveo was given to a patient by mistake) and administered drug to incorrect patient (Verbatim: menveo was given to a patient by mistake). The outcome of the extra dose administered, administered drug to incorrect patient and interchange of vaccine products were unknown. Additional Information: GSK Receipt Date: 09-JAN-2025 The other health professional reported that a dose of Menveo was given to a patient by mistake, mentions patient looked similar to her sister who was supposed to be vaccinated with menveo, so the wrong patient got vaccinated which led to administered drug to incorrect patient. The patient also received gardasil vaccine on the same clinic day. The patient had Menactra first dose and the patient received Menveo dose (2 vials presentation) which led to interchange of vaccine products. 18 year old patient received 2 doses of Menveo which led to extra dose administered.
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| 2824539 | M | WV | 02/04/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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got Twinrix injection on 16Nov2024 and he is just now returning for 2nd dose; This non-serious case ...
got Twinrix injection on 16Nov2024 and he is just now returning for 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received first dose of Twinrix on 16th November 2024). On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: got Twinrix injection on 16Nov2024 and he is just now returning for 2nd dose). The outcome of the incomplete course of vaccination was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 10-JAN-2025 The pharmacist reported that the patient got Twinrix injection and he was just returning for the 2nd dose at time of reporting. Till the time of reporting the patient did not receive the second dose of Twinrix which led to incomplete course of vaccination.
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| 2824540 | U | GA | 02/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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received their first dose of Shingrix 5 years ago; This non-serious case was reported by a pharmacis...
received their first dose of Shingrix 5 years ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received their first dose of Shingrix 5 years ago ). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received their first dose of Shingrix 5 years ago ). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK receipt date: 13-JAN-2025 Pharmacist called reporting a received their first dose of Shingrix 5 years ago and pharmacist was looked for recommendations for how to proceed with series. Did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
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| 2824541 | 1 | M | CO | 02/04/2025 |
HIBV |
GLAXOSMITHKLINE BIOLOGICALS |
3G57J |
Expired product administered
Expired product administered
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Expired Product Used/patient received Hiberix which was expired on 09th Jan; This non-serious case w...
Expired Product Used/patient received Hiberix which was expired on 09th Jan; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-month-old male patient who received Hib (Hiberix) (batch number 3G57J, expiry date 09-JAN-2025) for prophylaxis. On 13-JAN-2025, the patient received Hiberix. On 13-JAN-2025, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: Expired Product Used/patient received Hiberix which was expired on 09th Jan). The outcome of the expired vaccine used was unknown. Additional Information: GSK receipt date: 16-DEC-2024 Other HCP reported that 12 month old male patient was administered a dose of Hiberix 13th JAN, 2025, which had an expiration date of 09th JAN, 2025, which led to expired vaccine used. At the time of reporting, no additional doses had been administered.
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| 2824542 | 80 | M | FL | 02/04/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
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Extra dose administered, Wrong product administered
Extra dose administered, Wrong product administered
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Medication error; he was given another RSV shot by mistake; This non-serious case was reported by a ...
Medication error; he was given another RSV shot by mistake; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong vaccine administered in a 80-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included Pneumococcal vaccine for prophylaxis. Previously administered products included Arexvy (received an RSV vaccination 6 months ago). On 10-JAN-2025, the patient received the 2nd dose of Arexvy. On an unknown date, the patient received Pneumococcal vaccine. On 10-JAN-2025, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: Medication error) and extra dose administered (Verbatim: he was given another RSV shot by mistake). The outcome of the wrong vaccine administered and extra dose administered were unknown. Additional Information: GSK Receipt Date: 14-JAN-2025 The patient reported that he received an RSV vaccination 6 months ago at a pharmacy. The patient reported that his physician office called a few days ago and asked him to come in to receive a pneumonia shot and was later informed that he was given another RSV shot by mistake which led to wrong vaccine administered and extra dose administered.
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| 2824543 | 77 | F | OH | 02/04/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
|
Extra dose administered
Extra dose administered
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patient received second dose of Arexvy; This non-serious case was reported by a consumer via call ce...
patient received second dose of Arexvy; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 77-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Previously administered products included Arexvy (Patient received first dose one year ago). On 13-JAN-2025, the patient received the 2nd dose of Arexvy (intramuscular, right deltoid). On 13-JAN-2025, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: patient received second dose of Arexvy). The outcome of the extra dose administered was unknown. Additional Information: GSK Receipt Date: 14-JAN-2025 The patient reported that she received Arexvy vaccine twice, which led to extra dose administered.
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| 2824544 | U | CA | 02/04/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
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Extra dose administered
Extra dose administered
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7 patients received a second dose of Arexvy; This non-serious case was reported by a nurse via call ...
7 patients received a second dose of Arexvy; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in an specified number of patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received the 2nd dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: 7 patients received a second dose of Arexvy). The outcome of the extra dose administered was unknown. Additional Information: GSK Receipt Date: 14-JAN-2025 Reporter stated that 7 patients received a second dose of Arexvy, which led to extra dose administered. The patients were fine and no more specific information of the patients or the lot numbers and expiration dates of the vaccines were provided.
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| 2824545 | 18 | M | TX | 02/04/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
342RC |
Incorrect route of product administration
Incorrect route of product administration
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Priorix was mistakenly given in the deltoid muscle rather than subcutaneously; This non-serious case...
Priorix was mistakenly given in the deltoid muscle rather than subcutaneously; This non-serious case was reported by a nurse via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 18-year-old male patient who received MMR (Priorix) (batch number 342RC, expiry date 01-MAY-2025) for prophylaxis. On 15-JAN-2025, the patient received Priorix (intramuscular, unknown deltoid). On 15-JAN-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix was mistakenly given in the deltoid muscle rather than subcutaneously). The outcome of the subcutaneous injection formulation administered by other route was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 15-JAN-2025 The reporter was the Healthcare Professional. Priorix was mistakenly given in the deltoid muscle rather than subcutaneously which led to Subcutaneous injection formulation administered by other route. Nothing else was reported.
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| 2824546 | F | FL | 02/04/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255T2 |
Extra dose administered
Extra dose administered
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a second dose was administered; This non-serious case was reported by a pharmacist via call center r...
a second dose was administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 84-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 255T2, expiry date 05-DEC-2025) for prophylaxis. Previously administered products included Arexvy (received 1st dose a year ago). On 21-JAN-2025, the patient received the 2nd dose of Arexvy. On 21-JAN-2025, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: a second dose was administered). The outcome of the extra dose administered was unknown. Additional Information: GSK Receipt Date: 22-JAN-2025 The pharmacist reported that a patient received a first dose of Arexvy last year and a second dose was administered which led to extra dose administered. The pharmacist asked for potential adverse effects.
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| 2824547 | F | FL | 02/04/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255T2 |
Injection site erythema, Injection site mass, Injection site pain, Injection sit...
Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus
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experienced soreness at the injection site; a small bump at the injection site; itching at the injec...
experienced soreness at the injection site; a small bump at the injection site; itching at the injection site; large red area surrounding the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 255T2, expiry date 05-DEC-2025) for prophylaxis. On 09-JAN-2025, the patient received Arexvy (intramuscular). On 09-JAN-2025, less than a day after receiving Arexvy, the patient experienced injection site erythema (Verbatim: large red area surrounding the injection site) and injection site itching (Verbatim: itching at the injection site). On 10-JAN-2025, the patient experienced injection site pain (Verbatim: experienced soreness at the injection site) and injection site mass (Verbatim: a small bump at the injection site). The outcome of the injection site erythema and injection site itching were not resolved and the outcome of the injection site pain and injection site mass were resolved. It was unknown if the reporter considered the injection site erythema, injection site pain, injection site mass and injection site itching to be related to Arexvy. It was unknown if the company considered the injection site erythema, injection site pain, injection site mass and injection site itching to be related to Arexvy. Additional Information: GSK Receipt Date: 24-JAN-2025 The reporter reported that she received her Arexvy vaccine on 9th January 2025. Later the day of reporting she noticed a large red area surrounding the injection site that had faded somewhat but was still visible. She also experienced soreness, a small bump and itching at the injection site. The itching was milder but still present. The bump and soreness had resolved.
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| 2824548 | F | 02/04/2025 |
COVID19 |
JANSSEN |
Unknown |
Death
Death
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DEATH; This spontaneous report received from a consumer concerned an elderly female patient via soci...
DEATH; This spontaneous report received from a consumer concerned an elderly female patient via social media. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced death. (dose series 1). It was unknown if an autopsy was performed. The action taken with janssen covid-19 vaccine was not applicable. Reported cause of death was unknown cause of death. The patient died on an unspecified date. The reporter considered the causality between janssen covid-19 vaccine and death as related. Company causality between janssen covid-19 vaccine and death as possible. This report was serious (death).; Sender's Comments: V0; Death; The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: unknown cause of death
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| 2824549 | 47 | F | NY | 02/04/2025 |
COVID19 |
MODERNA |
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Rotator cuff syndrome
Rotator cuff syndrome
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rotator cuff issue / Severe arm pain / trouble moving the arm in which I had the vaccine (right)/pai...
rotator cuff issue / Severe arm pain / trouble moving the arm in which I had the vaccine (right)/pain in the other arm (left) while still having mild pain in the right; This spontaneous case was reported by a patient and describes the occurrence of ROTATOR CUFF SYNDROME (rotator cuff issue / Severe arm pain / trouble moving the arm in which I had the vaccine (right)/pain in the other arm (left) while still having mild pain in the right) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 03-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In November 2024, the patient experienced ROTATOR CUFF SYNDROME (rotator cuff issue / Severe arm pain / trouble moving the arm in which I had the vaccine (right)/pain in the other arm (left) while still having mild pain in the right). At the time of the report, ROTATOR CUFF SYNDROME (rotator cuff issue / Severe arm pain / trouble moving the arm in which I had the vaccine (right)/pain in the other arm (left) while still having mild pain in the right) had not resolved. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. No concomitant medication was reported. Patient had severe arm pain and trouble moving the arm in which she had the vaccine (right). After a week, she experienced pain in the other arm (left) while still having mild pain in the right. As of now (28 January 2025) she had still pain in the left arm which has been diagnosed as a rotator cuff issue. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.
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| 2824550 | 41 | M | TX | 02/04/2025 |
COVID19 |
MODERNA |
053e21a |
Blood pressure measurement, Hypertension
Blood pressure measurement, Hypertension
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I have been experiencing higher than normal blood pressure over the last 2 years; This spontaneous c...
I have been experiencing higher than normal blood pressure over the last 2 years; This spontaneous case was reported by a patient and describes the occurrence of HYPERTENSION (I have been experiencing higher than normal blood pressure over the last 2 years) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028k21a and 053e21a) for COVID-19 prophylaxis. The patient's past medical history included COVID-19 on 15-Dec-2020. Concurrent medical conditions included ADHD and Osteoarthritis. On 22-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 15-Jun-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERTENSION (I have been experiencing higher than normal blood pressure over the last 2 years). At the time of the report, HYPERTENSION (I have been experiencing higher than normal blood pressure over the last 2 years) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Blood pressure measurement: higher than normal blood pressure over the last 2 years. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported.
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| 2824551 | F | 02/04/2025 |
COVID19 |
MODERNA |
UNKNOWN |
Dizziness, Vomiting
Dizziness, Vomiting
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She is very dizzy/dizziness/has to hold onto walls to walk; she feels like vomiting/she has thrown u...
She is very dizzy/dizziness/has to hold onto walls to walk; she feels like vomiting/she has thrown up many times; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (She is very dizzy/dizziness/has to hold onto walls to walk) and VOMITING (she feels like vomiting/she has thrown up many times) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. UNKNOWN) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (She is very dizzy/dizziness/has to hold onto walls to walk) and VOMITING (she feels like vomiting/she has thrown up many times). At the time of the report, DIZZINESS (She is very dizzy/dizziness/has to hold onto walls to walk) and VOMITING (she feels like vomiting/she has thrown up many times) had not resolved. No concomitant medications were reported. The patient was very dizzy/dizziness/had to hold onto walls to walk and she felt like vomiting/she had thrown up many times and sick from the shot, she had it 10 days ago. She was very dizzy and felt like vomiting. Her husband who was a doctor called in and got nothing from people. The patient holds onto walls to walk, and she had thrown up many times. No treatment medications were reported.
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| 2824552 | 22 | F | MN | 02/04/2025 |
RSV |
PFIZER\WYETH |
LN5502 |
Chills, Pain
Chills, Pain
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chills; body aches; temperature 99.6 F/100F; Thought they had given an HPV Vaccine, but instead they...
chills; body aches; temperature 99.6 F/100F; Thought they had given an HPV Vaccine, but instead they had given Abrysvo; This is a spontaneous report received from a Pharmacist, Program ID. A 22-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 11Nov2024 as dose 1, single (Lot number: LN5502, Expiration Date: 10Jan2025) at the age of 22 years intramuscular, in right deltoid for immunisation. The patient didn't receive hpv vaccine (HPV VACCINE). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 11Nov2024, outcome "unknown", described as "Thought they had given an HPV Vaccine, but instead they had given Abrysvo"; CHILLS (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body aches"; PYREXIA (non-serious), outcome "unknown", described as "temperature 99.6 F/100F". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was reported that Abryvso vaccine was given to the wrong patient. The patient is post-partum. They thought they had given an HPV Vaccine, but instead they had given Abrysvo. The patient did not receive any other vaccine on the same day as the Pfizer vaccine. The patient was not taking any other medications within 2 weeks prior to the event onset. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The patient did not previously receive the Pfizer suspect vaccine. The patient was not allergic to ang previous vaccinations, medications, food or other products. There was no any other diagnosed illness/medical history/chronic health conditions. The event did not require a visit to the emergency room or physician's office. Treatment was not received for the adverse event. There was no adverse events following this vaccination. Amendment: This follow-up report is being submitted to amend previously reported information: suspect vaccine Indication was updated from "Maternal exposure timing unspecified" to "Immunization". Follow-up (16Jan2025): Follow-up attempts are completed. Batch/lot number is not provided, and it cannot be obtained. Follow-up (29Jan2025): This is a spontaneous follow-up report received from a Pharmacist in response to follow-up letter. Updated information: patient's details (name, date or birth, age, weight, height) added, product details (vaccination date, anatomical location, route, dose number, lot number, expiration date), event details (onset date), removed event Drug use in unapproved population, new event chills, General body pain, fever added, additional information added.
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| 2824553 | F | CT | 02/04/2025 |
COVID19 |
PFIZER\BIONTECH |
F00809 |
Cold sweat, Fatigue, Feeling hot, Hypersomnia
Cold sweat, Fatigue, Feeling hot, Hypersomnia
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clammy; overheated ,hot and clammy; severe exhaustion/tired all the time; she sleeps 10 to 12 hours;...
clammy; overheated ,hot and clammy; severe exhaustion/tired all the time; she sleeps 10 to 12 hours; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 68-year-old female patient received BNT162b2 (BNT162B2), on 09Sep2021 as dose 1, single (Lot number: F00809), in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Surgery for lung cancer", start date: 2017, stop date: 2017, notes: It was removed & has not reoccurred. No test results to include, everything seems back to normal; "Lung cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Mumps and measles vaccines (dose number unknown, manufacturer unknown; received as a kid), for Immunisation; Flu vaccine (over the years got the annual flu vaccine), for Immunisation. The following information was reported: COLD SWEAT (non-serious), outcome "not recovered", described as "clammy"; FEELING HOT (non-serious), outcome "not recovered", described as "overheated ,hot and clammy"; FATIGUE (non-serious), outcome "unknown", described as "severe exhaustion/tired all the time"; HYPERSOMNIA (non-serious), outcome "unknown", described as "she sleeps 10 to 12 hours". Additional information: The patient got her vaccine in 2021 since then and with time she was more warm and she had to find ways to keep cool, she was wearing shorts during winter and it was to a point where it was becoming ridiculous. She also had severe exhaustion, she sleeps 10 to 12 hours, and was tired all of the time, and if years later this could be related to the vaccine. How long would this last. The patient complained about feeling overheated, hot, and clammy. As stated, the patient got the vaccines a few years ago and it started since got them and continued till today and wondering if was a side effect.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500021957 same reporter/vaccine/patient, different dose and event;
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| 2824554 | 77 | F | NC | 02/04/2025 |
COVID19 COVID19 COVID19 COVID19 FLUX FLUX |
MODERNA MODERNA PFIZER\BIONTECH PFIZER\BIONTECH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Abdominal discomfort, Burning sensation, Disturbance in attention, Headache, Hyp...
Abdominal discomfort, Burning sensation, Disturbance in attention, Headache, Hyperaesthesia; Memory impairment, Nausea, Ocular discomfort, Pain in extremity, Paraesthesia; Abdominal discomfort, Burning sensation, Disturbance in attention, Headache, Hyperaesthesia; Memory impairment, Nausea, Ocular discomfort, Pain in extremity, Paraesthesia; Abdominal discomfort, Burning sensation, Disturbance in attention, Headache, Hyperaesthesia; Memory impairment, Nausea, Ocular discomfort, Pain in extremity, Paraesthesia
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burning; Nauseous; tingling; had something wrong with my eyes/ eyes were like moving around/ eyes is...
burning; Nauseous; tingling; had something wrong with my eyes/ eyes were like moving around/ eyes is going circles or go cross eyes; sick to my stomach; had a strange like I felt sensitivity in my hands all night long/ could not touch my hands, it is like the skin was sensitive; headache/ terrible headache that is possibly the worst headache I have ever had in my life, just weird headache; pain in my hands that weird pain; cannot remember things; Cannot concentrate; This is a spontaneous report received from a Nurse. A 77-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 27Jan2025 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 27Jan2025 as dose number unknown, single), in right arm for immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "Cardiac arrhythmia" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; FLECAINIDE; ARMOUR THYROID. Vaccination history included: Rsv vaccine, for immunization. The following information was reported: DISTURBANCE IN ATTENTION (non-serious) with onset Jan2025, outcome "unknown", described as "Cannot concentrate"; MEMORY IMPAIRMENT (non-serious) with onset Jan2025, outcome "unknown", described as "cannot remember things"; PAIN IN EXTREMITY (non-serious) with onset Jan2025, outcome "unknown", described as "pain in my hands that weird pain"; HYPERAESTHESIA (non-serious) with onset 27Jan2025, outcome "unknown", described as "had a strange like I felt sensitivity in my hands all night long/ could not touch my hands, it is like the skin was sensitive"; HEADACHE (non-serious) with onset 27Jan2025, outcome "unknown", described as "headache/ terrible headache that is possibly the worst headache I have ever had in my life, just weird headache"; NAUSEA (non-serious) with onset 28Jan2025, outcome "recovering", described as "Nauseous"; BURNING SENSATION (non-serious) with onset 28Jan2025, outcome "unknown", described as "burning"; OCULAR DISCOMFORT (non-serious) with onset 28Jan2025, outcome "unknown", described as "had something wrong with my eyes/ eyes were like moving around/ eyes is going circles or go cross eyes"; ABDOMINAL DISCOMFORT (non-serious) with onset 28Jan2025, outcome "unknown", described as "sick to my stomach"; PARAESTHESIA (non-serious) with onset 28Jan2025, outcome "unknown", described as "tingling". Therapeutic measures were taken as a result of headache, pain in extremity. Additional information: The patient had the Pfizer, Moderna shot this week on the 27th and she had horrible side effects. She was a medical professional. So, she know there were nothing she could do. However, she was having, comes with her head. The first day at night, She had a strange like she felt sensitivity in her hands all night long. She could not touch her hands, it was like the skin was sensitive then and a headache, she had this weird headache. So, when she got up the next morning and she knew because she was kind of sensitive to anything. So, but I had RSV this year and she was worried what was going to happen if she get COVID? She was in her 70s and she was worried. The next day the 28th, when she got up in the morning. she had a terrible headache that was possibly the worst headache she had ever had in her life, just weird headache. It was like burning and tingling and it seems like poking at me and then her eyes, I had something wrong with her eyes. Her eyes were like moving around, like there was a name for it, what was the name of that? Anyways, your eyes was going circles or go cross eyes and what else and she was sick to her stomach, not really bad sick because she did not really get sick to her stomach but she felt she was nauseous and then today, I am feeling better. However, her head is a mess. I cannot concentrate. I cannot remember things like if she did a task, she could not remember if she finished it, where she left it, that kind of thing like she was doing laundry and then she walked away to get something and then when she came back she could not remember what she was doing. The worst part was she have to drive and she almost had a horrible accident, they had this the one lane with the truck but they did not really have enough signs up for and the guy in front of her was blocking her view and he got into the left hand lane around that truck that has a arrow on it which she did not see at all and I normally would see it but obviously I cannot concentrate and she wanted they to know she just saw her life go before her, making it around that big neck truck and then she slowed down, she did not speed, she was retired. So, it was very scary. So, she was calling you to tell you this adverse reaction that she had is abnormal. she know it falls into the categories of the reactions to this new drug, she know it does, she read up on it. Unfortunately, she did not read up before I took the shot. So, she probably would have asked for another shot because she took Pfizer the last." When probed for the name of the shot, consumer stated, "I took Moderna. That said Pfizer Moderna, COVID (It was further not clarified if took both Pfizer and Moderna Covid-19 vaccine. Hence, both captured as suspect). That was right, she forget that Pfizer had many vaccines. I work for pharmaceutical company. It was Moderna, the new 2024. She did not put any of the name on her slip because they do not have to do that anymore." When clarified if Pfizer COVID-19 Vaccine, consumer stated, "Yes, I just said that to you, it was COVID this year. Yes." She was Nurse, retired. Weight: Consumer stated, "Her weight is 147 that is what clothes on. However, because that is what they do here to make everybody look fat. So, her real weight is 130. It weighs maybe with shoes, pants, top, sweater, jacket. So, I weigh 130, I know I weigh 130 because I weigh herself on the scale so, that is her normal weight." Country of Incidence . If vaccination card handy for product details (LOT#, expiration date, NDC# and UPC#): Consumer stated, "No, they do not log anymore. I did bring a card, they do not do it anymore. They do not have to by our state law." Vaccination facility name: Consumer stated, "It is a COVID vaccination, Moderna and I got it at Pharmacy." Vaccination facility type: Pharmacy. Other medical conditions and concomitant medications: Consumer stated, "I am taking meds for cardiac arrythmias. I do not have a heart condition. It is not considered a heart condition and then I take a Thyroid pill, I am hypothyroid." Lab work: Consumer stated, "No, I have her blood will be done next week. I am due I think next Friday and then, I have an appointment the next day but that is what her endocrinologist. I do not get it tested to regular doctor so." When probed if any same date vaccination with Pfizer COVID-19 vaccine, consumer stated, "I did actually in a different arm. I took the Flu vaccine. I cannot name it, I have no idea (Hence, suspect captured as Unspecified Flu Vaccine). It is this year's flu. They do not write those things down and I am not really interested, I just take whatever they are giving. I do not thing there is a specific one that you can ask for, it is what the pharmacy." If vaccination card handy for product details (LOT#, expiration date, NDC# and UPC#): Consumer stated, "They do not require that card anymore and I asked her to write it down for me. So, obviously I have not liked the fact that the doctor's office does not do it anymore but and I go to the cleanest pharmacy in her area and that is why I go to the pharmacy because they have a little vaccination area with brand new chairs and a blood pressure machine and the thermometer, disposable thermometer. They have got all that stuff there, that is why I went. The other ones are pharmacy is disgusting and the other one pharmacy is disgusting too and there is a whole bunchy of people around the area and you have no privacy. This is a nice pharmacy, that is everything to me as a nurse. That is why I want to go." When probed if any four weeks prior vaccination with Pfizer COVID-19 vaccine, consumer stated, "No." Treatment: Consumer stated, "Well, I took her daily medications before I went and I think I might have taken. No, I did not take anything that day. she did not need to take anything but the next day I took Tylenol for the pain in her hands that weird pain and for the headache." Anatomical location of vaccination: Consumer stated, "It is a left arm." Reassurance: Consumer stated, "No, she did not have. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2824555 | F | CT | 02/04/2025 |
COVID19 |
PFIZER\BIONTECH |
301358A |
Cold sweat, Condition aggravated, Feeling hot, Inappropriate schedule of product...
Cold sweat, Condition aggravated, Feeling hot, Inappropriate schedule of product administration
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feeling hot; feeling hot and each year it seems to be getting worse; clammy; 1st covid vaccine given...
feeling hot; feeling hot and each year it seems to be getting worse; clammy; 1st covid vaccine given 09Sep2021; 2nd covid vaccine given on 21Sep2021; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 68-year-old female patient received BNT162b2 (BNT162B2), on 21Sep2021 as dose 2, single (Lot number: 301358A) for covid-19 immunisation. The patient's relevant medical history included: "lung cancer" (unspecified if ongoing), notes: It was removed & has not reoccurred. No test results to include, everything seems back to normal; "lung cancer surgery", start date: 2017, stop date: 2017. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 1, lot number: F00809), administration date: 09Sep2021, for COVID-19 immunisation, reaction(s): "feeling hot", "severe exhaustion/tired all the time", "sleeps 10 to 12 hours", "clammy"; Mumps vaccine (dose number unknown, manufacturer unknown, as a kid), for immunisation; Measles vaccine (dose number unknown, manufacturer unknown, as a kid), for immunisation; Flu vaccine (annually, over the years), for immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Sep2021, outcome "unknown", described as "1st covid vaccine given 09Sep2021; 2nd covid vaccine given on 21Sep2021"; FEELING HOT (non-serious), outcome "not recovered"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "feeling hot and each year it seems to be getting worse"; COLD SWEAT (non-serious), outcome "unknown", described as "clammy". Additional information: Patient was employed. She received the vaccine in the left shoulder. Patient has no prior vaccinations (within 4 weeks). Patient was feeling hot. Each year, it seems to be getting worse. It will be 50 something degrees. Patient will be feeling hot and clammy. Inside the house, the temperature will be 62 degrees. During the summer, patient was very concerned because when it does get hot inside, she continues to get hotter. Patient was fine on the other medications taking before. She feels like it's the vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500021408 same patient/drug, different event/dose;
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| 2824556 | M | 02/04/2025 |
COVID19 |
PFIZER\BIONTECH |
ER8734 |
Headache, Hyperhidrosis, Nausea, Pyrexia, Vomiting
Headache, Hyperhidrosis, Nausea, Pyrexia, Vomiting
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got very hot and feverish; threw up; sweaty; nausea; headache; This is a spontaneous report received...
got very hot and feverish; threw up; sweaty; nausea; headache; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-781244 (Moderna). A male patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Lot number: ER8734) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single; Lot number: EN6207), administration date: 17Mar2021, for COVID-19 immunization, reaction(s): "got very hot and feverish". The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "got very hot and feverish"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021); NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021); HYPERHIDROSIS (non-serious) with onset 2021, outcome "recovered" (2021), described as "sweaty"; VOMITING (non-serious) with onset 2021, outcome "recovered" (2021), described as "threw up". Additional information: Patient was curious about getting an update on his COVID-19 shots, had 3 shots back in 2021 and they were all Pfizer shots. Patient was asking if it matter if the patient update the shots with the Moderna vaccine and was planning on getting his shot. Patient expects to get mild symptoms, is pretty healthy, the last time had a shot, had a different reaction on all 3 different shots, pretty sick. Patient did not have the expiration date or the dose volume of the 3 shots written on his vaccination card. Patient clarified also got very hot and feverish for all 3 doses. One of them had a pretty bad headache too, probably with the second dose. Patient noted the second dose was the most traumatic since experienced the most, all of it, the hot and throwing up and the headache. Patient experienced really high temperature, got really-everything got really hot and sweaty, experienced nausea and throwing up on his second dose. On the 3rd dose, got really hot, but doesn't know if it would be considered a high fever, sweaty stuff. The symptoms came and went pretty quick. It all came and went pretty quick as far as the patient can remember, within the next day was doing better. Patient later mentioned being older, got to be more of at risk (referring to his risk of COVID-19). No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500022036 Same patient/vaccine, different dose/AE;US-PFIZER INC-PV202500012460 Same patient/vaccine, different dose/AE;
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| 2824557 | M | 02/04/2025 |
COVID19 |
PFIZER\BIONTECH |
30155BA |
Hyperhidrosis, Pyrexia
Hyperhidrosis, Pyrexia
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got very hot and feverish; Sweaty stuff; This is a spontaneous report received from a Consumer or ot...
got very hot and feverish; Sweaty stuff; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-781244 (Moderna). A patient (age and gender not provided) received BNT162b2 (BNT162B2), on 23Nov2021 as dose 3 (booster), single (Lot number: 30155BA) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "got very hot and feverish"; HYPERHIDROSIS (non-serious), outcome "recovered", described as "Sweaty stuff". Additional information: Patient was curious about getting an update on his COVID-19 shots, had 3 shots back in 2021 and they were all Pfizer shots. Patient was asking if it matter if the patient update the shots with the Moderna vaccine and was planning on getting his shot. Patient expects to get mild symptoms, is pretty healthy, the last time had a shot, had a different reaction on all 3 different shots, pretty sick. Patient did not have the expiration date or the dose volume of the 3 shots written on his vaccination card. Patient clarified also got very hot and feverish for all 3 doses. One of them had a pretty bad headache too, probably with the second dose. Patient noted the second dose was the most traumatic since experienced the most, all of it, the hot and throwing up and the headache. Patient experienced really high temperature, got really-everything got really hot and sweaty, experienced nausea and throwing up on his second dose. On the 3rd dose, got really hot, but doesn't know if it would be considered a high fever, sweaty stuff. The symptoms came and went pretty quick. It all came and went pretty quick as far as the patient can remember, within the next day was doing better. Patient later mentioned being older, got to be more of at risk (referring to his risk of COVID-19). No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500012460 Same patient/vaccine, different dose/AE;US-PFIZER INC-202500022035 Same patient/vaccine, different dose/AE;
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| 2824558 | 50 | F | 02/04/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
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Anal pruritus, Confusional state, Fatigue, Injection site pain, Mass; Sleep diso...
Anal pruritus, Confusional state, Fatigue, Injection site pain, Mass; Sleep disorder, Tongue biting, Urticaria
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it may have been a seizure; biting my tongue; feeling confused; arm soreness around the injection si...
it may have been a seizure; biting my tongue; feeling confused; arm soreness around the injection site; hive; itching; being tired; This is a spontaneous report received from an Other HCP. A 50-year-old female patient (not pregnant) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 29Jan2025 at 09:45 as dose number unknown, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), on 04Jan2025 as dose 1, single, in left arm for immunisation. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing); "tubular adenoma" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "chronic diarrhea" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "fibroids" (unspecified if ongoing); "myopia" (unspecified if ongoing); "dyslipidemia" (unspecified if ongoing); "known allergies: PCN" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing); "known allergies: Adhesives" (unspecified if ongoing); "known allergies: IV contrast" (unspecified if ongoing); "known allergies: cocoa butter" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; VALACYCLOVIR [VALACICLOVIR]; LOSARTAN; AMLODIPINE; FAMOTIDINE. Past drug history included: Celebrex, reaction(s): "known allergies"; Itraconazole, reaction(s): "known allergies"; Nitrofurantoin, reaction(s): "known allergies"; Tolfaftate, reaction(s): "known allergy"; Glucagon, reaction(s): "known allergies". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 29Jan2025 at 21:15, outcome "recovering", described as "arm soreness around the injection site"; FATIGUE (non-serious) with onset 29Jan2025 at 21:15, outcome "recovering", described as "being tired"; TONGUE BITING (non-serious) with onset 29Jan2025 at 21:15, outcome "recovering", described as "biting my tongue"; CONFUSIONAL STATE (non-serious) with onset 29Jan2025 at 21:15, outcome "recovering", described as "feeling confused"; URTICARIA (non-serious) with onset 29Jan2025 at 21:15, outcome "recovering", described as "hive"; SEIZURE (medically significant) with onset 29Jan2025 at 21:15, outcome "recovering", described as "it may have been a seizure"; PRURITUS (non-serious) with onset 29Jan2025 at 21:15, outcome "recovering", described as "itching". The clinical course was reported as follows: The patient got the shot (as reported) on 29Jan2025 morning, she developed a little arm soreness around the injection site. Additionally, she was lying in her bed in the evening and about 12 hours after the shot, fell asleep and then woke up a few minutes later biting her tongue and feeling confused; it may have been a seizure. Within minutes of this possible seizure, she got a very itchy hive in her butt crack (gluteal cleft). The itching was so severe it kept her awake much of the night. It was a lump that she couldn't see because of the location, but she could feel with her fingertips. Treated it with topical hydrocortisone and topical diphenhydramine that only helped partially. It was less itchy on 30Jan2025 morning but still lumpy. She did not have any other hives or rashes, and other than being tired. Was fine on 30Jan2025 morning, no more potential seizure activity, she reported she did not have epilepsy. Therapeutic measures were not taken as a result of seizure, vaccination site pain, tongue biting, confusional state, fatigue. Therapeutic measures were taken as a result of urticaria, pruritus. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported event seizure was related to the suspect product event most likely due to patient underlying contributory factors. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate.
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| 2824559 | F | NY | 02/04/2025 |
COVID19 |
PFIZER\BIONTECH |
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Chills, Pyrexia
Chills, Pyrexia
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chills; fever; This is a spontaneous report received from a Consumer or other non HCP from medical i...
chills; fever; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "recovered"; PYREXIA (non-serious), outcome "recovered", described as "fever". Additional information: Patient mentioned the she have had COVID vaccinations, and she got a reaction to that. She got a fever and chills, It last for a day and it's gone. (...) These were the things not made in public, she did read the information when the pharmacist told her what she was going to give her. She did read it thoroughly because again, COVID knocked her sideways but they seem to be okay. But had she known there were some instances of extreme fatigue, systemic muscle pain, she would have drawn another one. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2824560 | U | TX | 02/04/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
FE3592 FE3592 |
Abdominal pain, Cachexia, Chest pain, Fatigue, Illness; Pain
Abdominal pain, Cachexia, Chest pain, Fatigue, Illness; Pain
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Cachexia; body pain; sick; tired; abdominal pain; chest pain; This is a spontaneous report received ...
Cachexia; body pain; sick; tired; abdominal pain; chest pain; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Lot number: FE3592) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CACHEXIA (medically significant), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body pain"; ILLNESS (non-serious), outcome "unknown", described as "sick"; FATIGUE (non-serious), outcome "unknown", described as "tired"; ABDOMINAL PAIN (non-serious), outcome "unknown"; CHEST PAIN (non-serious), outcome "unknown". The patient stated, "What should I do now that I am dying almost 4 years after getting the Pfizer vaccine 2021? I have been diagnosed with Cachexia." Since getting the vaccine, the patient had been so weak, sick and tired with many any visits to the ER for abdominal pain. Patient had had chest pain and body pain since receiving the vaccine.
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| 2824561 | M | 02/04/2025 |
COVID19 |
PFIZER\BIONTECH |
EN6207 |
Pyrexia
Pyrexia
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got very hot and feverish; This is a spontaneous report received from a Consumer or other non HCP. O...
got very hot and feverish; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-781244 (Moderna). A male patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6207) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "got very hot and feverish". Additional information: Patient was curious about getting an update on his COVID-19 shots, had 3 shots back in 2021 and they were all Pfizer shots. Patient was asking if it matter if the patient update the shots with the Moderna vaccine and was planning on getting his shot. Patient expects to get mild symptoms, is pretty healthy, the last time had a shot, had a different reaction on all 3 different shots, pretty sick. Patient did not have the expiration date or the dose volume of the 3 shots written on his vaccination card. Patient clarified also got very hot and feverish for all 3 doses. The symptoms came and went pretty quick. It all came and went pretty quick as far as the patient can remember, within the next day was doing better. Patient later mentioned being older, got to be more of at risk (referring to his risk of COVID-19). No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500022035 Same patient/vaccine, different dose/AE;US-PFIZER INC-202500022036 Same patient/vaccine, different dose/AE;
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| 2824562 | F | NY | 02/04/2025 |
PNC20 |
PFIZER\WYETH |
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Condition aggravated, Fatigue, Inflammation, Pain
Condition aggravated, Fatigue, Inflammation, Pain
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She is still exhausted until now; inflammation response; severe pain flare-up/developed a tremendous...
She is still exhausted until now; inflammation response; severe pain flare-up/developed a tremendous pain; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID:. A 72-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 07Jan2025 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Pain" (unspecified if ongoing), notes: pain management patient. Concomitant medication(s) included: NOVOCAIN. The following information was reported: PAIN (medically significant) with onset 08Jan2025, outcome "recovering", described as "severe pain flare-up/developed a tremendous pain"; FATIGUE (non-serious), outcome "not recovered", described as "She is still exhausted until now"; INFLAMMATION (non-serious), outcome "unknown", described as "inflammation response". The event "severe pain flare-up/developed a tremendous pain" required physician office visit. Therapeutic measures were taken as a result of pain. Clinical course: On 29Jan2025, it was reported that the patient received the Prevnar 20 vaccine. The patient is a pain management patient and get biweekly trigger point injections to manage her pain. The day after the vaccine, she started to have a severe pain flare up that even additional trigger point injections didn't help. Her doctor said that she was having an inflammation response. The patient was still in pain and it's three weeks later. On 30Jan2025, additional context was reported: She is on pain management, and she has been getting biweekly trigger point injections to manage her pain which she was getting these trigger point injections prior to the administration of Prevnar 20. She mentioned that the trigger point injections include Novocain. Three days after receiving the Prevnar 20 vaccine, she developed a tremendous pain. She is still exhausted until now, and the pain is starting to decline in the past three days. The pain she experienced is enough to seek medical attention and agent stated she did seek medical attention. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
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| 2824563 | U | AL | 02/04/2025 |
COVID19 |
PFIZER\BIONTECH |
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Blood pressure measurement, Cerebrovascular accident, Hypertension, Nervous syst...
Blood pressure measurement, Cerebrovascular accident, Hypertension, Nervous system disorder
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stroke; It affected patient's whole body especially nervous system; High blood pressure; This i...
stroke; It affected patient's whole body especially nervous system; High blood pressure; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "It affected patient's whole body especially nervous system"; HYPERTENSION (non-serious), outcome "unknown", described as "High blood pressure". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: high. Clinical details: The patient had a severe reaction to the Pfizer vaccine. The first shot and only one. Dr's told the patient never to get another vaccine. It affected patient's whole body especially nervous system. High blood pressure along with having a stroke. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2824564 | 41 | U | 02/04/2025 |
TDAP |
SANOFI PASTEUR |
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Injection site erythema, Injection site warmth
Injection site erythema, Injection site warmth
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Injection site erythema; Injection site warmth; Initial information received on 31-Jan-2025 regardin...
Injection site erythema; Injection site warmth; Initial information received on 31-Jan-2025 regarding an unsolicited valid non-serious case received from Health Authorities via Nurse. This case involves a 41 years old and unknown gender patient who experienced injection site erythema and injection site warmth after receiving Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.5 ml dose once of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number, strength and expiry not reported) via intramuscular route in unknown administration site as Immunisation. There will be no information on batch number and expiration date corresponding to the one at time of event occurrence. On an unknown date the patient developed injection site erythema and injection site warmth (unknown latency) following the administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine. Action taken: not applicable. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was Unknown for the events.
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| 2824565 | 0.25 | F | FL | 02/04/2025 |
DTAPIPV DTAPIPVHIB |
SANOFI PASTEUR SANOFI PASTEUR |
U7931AB |
Wrong product administered; Wrong product administered
Wrong product administered; Wrong product administered
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dose of vQUADRACEL, was inadvertently administered to a patient under the age of 4 instead of Pentac...
dose of vQUADRACEL, was inadvertently administered to a patient under the age of 4 instead of Pentacel with no reported adverse event; Initial information received on 31-Jan-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves 3 months old female patient to whom inadvertently administered dose of diphtheria, tetanus, AC pertussis and IPV vaccine (Quadracel (VERO)) under the age of 4 instead of diphtheria, tetanus, ac pertussis, ipv and hib vaccine (pentacel (vero)) with no reported adverse event The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Rotavirus vaccine live oral 1v (Rotarix). On 30-Jan-2025, the patient received a dose of 0.5 ml of suspect diphtheria, tetanus, AC pertussis and IPV vaccine (Quadracel (VERO)), Solution for injection (strength : standard) (frequency: once) (lot U7931AB and expiry date 09-Nov-2025) via intramuscular route in the right thigh for immunization and had inadvertently administered to a patient under the age of 4 instead of pentacel (wrong product administered) (Latency: same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Contact specialty is PediatricReporter can be contacted by Sanofi:YesPotential PTC:NoDescription:This situation is pre-assessed as a medication error/an inappropriate use due to use of the product in a patient under the age of 4. Physician reporting that a dose of vQUADRACEL, was inadvertently administered to a patient under the age of 4 instead of Pentacel. Caller is inquiring if the dose is valid or does it need to be repeated.Additional Description of eventAdverse events :Physician reporting that a dose of vQUADRACEL, was inadvertently administered to a patient under the age of 4 instead of Pentacel. Caller is inquiring if the dose is valid or does it need to be repeated.Pasteur AE ReportingRefunds/Credits will not be issued due to adverse events. Patient Informationo Patient age <1 year enter as 2m, 4m, etc. Many pediatric vaccines needmonth for age. 3m Dosage Informationo Frequency = onceo Therapy Date: From = Date of immunization To = leave blanko Route = route & site INTRAMUSCULAR, RIGHT THIGH o Dose = 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test 0.5 mLo Strength = standard except for Fluzone High Doseo Indications = Immunization or TB skin test IMMUNIZATION Event Informationo Treatmento Dose # if serieso List concomitant or no other vaccines ORAL ROTARIXo ER/Dr. visit and date 30Jan2025o Lot # U7931ABo Vaccine presentation/NDC #49281-564-88 Administering physiciano Full Name MDo Address Phone number Reporter relationship : HCPProduct used : Used
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| 2824566 | U | UT | 02/04/2025 |
HIBV |
SANOFI PASTEUR |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
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patient received 2 doses of ACT-HIB with no reported adverse event; Initial information received on ...
patient received 2 doses of ACT-HIB with no reported adverse event; Initial information received on 31-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who experienced patient received 2 doses of ACT-HIB with no reported adverse event after receiving HIB (PRP/T) Vaccine [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Nov-2024, the patient received 2DF (dosage form) of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunization. Information on the batch number was requested corresponding to the one at time of event occurrence. On 18-Nov-2024, the patient developed patient received 2 doses of ACT-HIB with no reported adverse event (latency same day) following the administration of HIB (PRP/T) Vaccine. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2824567 | U | NY | 02/04/2025 |
TDAP |
SANOFI PASTEUR |
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Anaphylactic reaction
Anaphylactic reaction
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had an anaphylactic reaction to the tetanus vaccine, ADACEL; Initial information received on 31-Jan-...
had an anaphylactic reaction to the tetanus vaccine, ADACEL; Initial information received on 31-Jan-2025 regarding an unsolicited valid serious case received from a Nurse. This case involves an unknown age and unknown gender patient had an anaphylactic reaction to the tetanus vaccine, diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot number, expiry date and strength: not reported) via unknown route in unknown administration site for Immunization Information on batch number and expiry date corresponding to the one at time of event occurrence was requested On an unknown date the patient had an anaphylactic reaction to the tetanus vaccine, ADACEL (anaphylactic reaction) (latency unknown) Reportedly, the reporter do not know what component of ADACEL the patient reacted to. She asked if there were any components in TYHPHIM VI that are the same as ADACEL Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (anaphylactic reaction). At time of reporting, the outcome was Unknown for the event anaphylactic reaction. Seriousness Criteria: Medically significant for the event anaphylactic reaction; Sender's Comments: Sanofi Company Comment dated on 04-Feb-2025: Based on the information available, the role of the vaccine cannot be established. Further information regarding concurrent condition during vaccination, previous reaction to the vaccination or similar vaccine, tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed for complete assessment of the case. Based upon the reported information, the individual role of the suspect vaccine cannot be assessed.
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| 2824568 | F | NC | 02/04/2025 |
UNK |
UNKNOWN MANUFACTURER |
No batch number |
Cough, Fatigue, Influenza, Pyrexia, Respiratory tract congestion
Cough, Fatigue, Influenza, Pyrexia, Respiratory tract congestion
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Diagnosed with Influenza A; Fatigue; Fever; Coughing; Congestion; This spontaneous case, initially r...
Diagnosed with Influenza A; Fatigue; Fever; Coughing; Congestion; This spontaneous case, initially received on 21-Jan-2025, was reported by a non health professional and concerns a female patient with unknown age. No medical history or concomitant medications were reported. Administration of company suspect drug: On 24-Oct-2024, the patient received Flucelvax (TIV) for Active immunization for the prevention of influenza disease, dose, route of administration and route of administration: not reported, Lot number: not reported and wont be requested due to no follow-up consent. No additional suspect drugs. Adverse reactions/events and outcomes: On 19-Jan-2025, the patient experienced Diagnosed with Influenza A (Medically Significant, outcome: Unknown). Associated symptoms included: Standard symptoms of the flu - Fatigue, Fever, Coughing, Congestion. The patient reported that wanted to report an adverse event, with a special situation. She was vaccinated with Flucelvax on 24-Oct-2024. She was diagnosed with Influenza A on 19-Jan-2025 at Urgent Care, The patient was experiencing standard symptoms of the flu, including fatigue, fever, coughing, congestion etc. The patient has no other medical conditions. Non-drug treatment/Other action taken: Flucelvax (TIV) action taken: Not Applicable Reporter assessment: the reporter did not provide a seriousness and causality assessment for the event; Reporter's Comments: Due to the spontaneous nature of the case, it is considered related for reporting purposes. Of note, Influenza A occurred 2 months and 27 days post vaccination with Flucelvax. But, there is limited information regarding the laboratory tests for the confirmation of Influenza A.
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| 2824578 | U | CT | 02/04/2025 |
HPV9 |
MERCK & CO. INC. |
W026152 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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no adverse event; Clinic coordinator calling to report an expired dose of GARDASIL 9 was inadvertent...
no adverse event; Clinic coordinator calling to report an expired dose of GARDASIL 9 was inadvertently administered to a patient.; This spontaneous report was received from a clinic coordinator and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 30-JAN-2025, the patient was inadvertently vaccinated with an expired dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (lot #W026152 was verified to be a valid number, expiration date: 29-JAN-2025), administered for prophylaxis (dose, vaccination scheme, injection, strength, and route of administration were not provided) (expired product administered). The product did not undergo any temperature excursions and was supported per Post Expiry Memo. No additional adverse event was reported.
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| 2824579 | 33 | F | FL | 02/04/2025 |
VARCEL VARZOS |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
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No adverse event, Product administered to patient of inappropriate age, Wrong pr...
No adverse event, Product administered to patient of inappropriate age, Wrong product administered; No adverse event, Product administered to patient of inappropriate age, Wrong product administered
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No additional AE; On 22Jan2025 received SHINGRIX. On 03Feb2025 patient came in an they administered ...
No additional AE; On 22Jan2025 received SHINGRIX. On 03Feb2025 patient came in an they administered the VARIVAX.; On 22Jan2025 she was scheduled to get VARIVAX/ instead inadvertently received SHINGRIX; This spontaneous report has been received from a nurse concerning to a 33-year-old female patient. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter. It was reported that the patient needed to get varicella virus vaccine live (Oka/Merck) (VARIVAX) for her nursing school. On 22-JAN-2025, she was scheduled to get varicella virus vaccine live (Oka/Merck) (VARIVAX) but instead inadvertently received varicella zoster vaccine rge (cho) (SHINGRIX) as prophylaxis (formulation, strength, dose, route and anatomical location of administration, lot #, and expiration date were not provided) (wrong product administered). Later, on 03-FEB-2025 (reported as today) the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (strength, dose, route and anatomical location of administration, lot #, and expiration date were not provided) as prophylaxis (extra dose administered). No other information was known or reported. No side effects and no additional adverse event (AE) were reported. Lot # is being requested and will be submitted if received.
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| 2824580 | 1.25 | F | FL | 02/04/2025 |
RV5 |
MERCK & CO. INC. |
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Extra dose administered, Product administered to patient of inappropriate age, W...
Extra dose administered, Product administered to patient of inappropriate age, Wrong patient received product
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No adverse effects were reported.; HCP called to report that a healthy 15 month old female was given...
No adverse effects were reported.; HCP called to report that a healthy 15 month old female was given a 4th (extra) dose of ROTATEQ today (2/3/2025), above the maximum age limit for administration of ROTATEQ, even though it wasn't ordered for this specific patient. (It was stated that; HCP called to report that a healthy 15 month old female was given a 4th (extra) dose of ROTATEQ today (2/3/2025), above the maximum age limit for administration of ROTATEQ, even though it wasn't ordered for this specific patient. (It was stated that; HCP called to report that a healthy 15 month old female was given a 4th (extra) dose of ROTATEQ today (2/3/2025), above the maximum age limit for administration of ROTATEQ, even though it wasn't ordered for this specific patient. (It was stated that; This spontaneous report was received from a physician regarding a 15-month-old female. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. On 03-FEB-2025, the patient received a fourth (4th) an extra dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (formulation also reported as vial 2), 2 mL, administered orally for prophylaxis (strength, lot #, and expiry date were not provided), above the maximum age limit for administration of this vaccine, even though it had not been ordered her specifically (It was stated that it was not product confusion, but possibly given to the wrong patient) (Extra dose administered) (Product administered to patient of inappropriate age) (Wrong patient received product). However, No adverse effects were reported. No other information was provided at the time of the call. Additional information was not expected.
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| 2824581 | U | MA | 02/04/2025 |
HPV9 |
MERCK & CO. INC. |
W015894 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No side effects or symptoms reported; Nurse called to report GARDASIL 9 that expired 1/20/2025 was g...
No side effects or symptoms reported; Nurse called to report GARDASIL 9 that expired 1/20/2025 was given to a patient today, 2/3/2025. No side effects or symptoms reported. No temperature excursion on this product. Product supported by post expiry memo. No additional AE/no PQC.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported. On 03-FEB-2025, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, 0.5 milliliter (mL) once lot number W015894, expiration date 20-JAN-20225, as prophylaxis (expired product administered). No adverse event was reported.
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| 2824582 | 32 | F | HI | 02/04/2025 |
VARCEL |
MERCK & CO. INC. |
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Exposure during pregnancy, No adverse event
Exposure during pregnancy, No adverse event
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no side effects reported; She said she was given the VARIVAX vaccine when she was unaware that she w...
no side effects reported; She said she was given the VARIVAX vaccine when she was unaware that she was pregnant.; This prospective spontaneous report was received from patient refering to herself as a 32-year-old female pregnant. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 27-DEC-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (dose, vaccination scheme, injection site, strength, lot #, expiration date, and route of administration were not provided). It was reported that when she was given the she was unaware that she was pregnant (exposure during pregnancy); at the time of reporting she was 7 weeks of gestation. No side effects were reported. The pregnancy and fetal outcomes were unknown. Lot # is being requested and will be submitted if received.
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| 2824583 | U | 02/04/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; Still got them; This serious case was reported by a consumer via inte...
Suspected vaccination failure; Still got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Still got them). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 23-JAN-2025 This case was reported by the patient via interactive digital media. The patient had the vaccine and still got them (shingles). This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
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| 2824584 | M | 02/04/2025 |
COVID19 |
PFIZER\BIONTECH |
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Blood grouping, Lethargy, Mobility decreased
Blood grouping, Lethargy, Mobility decreased
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couldn't move for almost a year; lethargic in the chair; This is a spontaneous report received ...
couldn't move for almost a year; lethargic in the chair; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-781503 (Moderna). A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MOBILITY DECREASED (medically significant), outcome "unknown", described as "couldn't move for almost a year"; LETHARGY (non-serious), outcome "unknown", described as "lethargic in the chair". The patient was lethargic in the chair and couldn't move for almost a year, but had the "Pfizer. Believes the effects are because of "blood type" O negative, No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2824585 | 1.5 | M | MA | 02/04/2025 |
HIBV |
SANOFI PASTEUR |
UK169AB |
Diarrhoea, Hypophagia, Injection site erythema, Injection site swelling, Pyrexia
Diarrhoea, Hypophagia, Injection site erythema, Injection site swelling, Pyrexia
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Patient had redness and swelling at the site the next day.. Three days after he had fevers to 103 wh...
Patient had redness and swelling at the site the next day.. Three days after he had fevers to 103 which have persistent to day 6. He has diarrhea and decrease oral intake. In the office his vitals were normal 4 hours after tylenol, was more playful to mom and eating better. Red outline was still there but redness fading. Nontender
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| 2824597 | 65 | F | WA | 02/04/2025 |
PNC20 |
PFIZER\WYETH |
LJ5284 |
Injection site erythema, Injection site pruritus
Injection site erythema, Injection site pruritus
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PATIENT RECEIVED PREVNAR 20 ON 1/28/25. SHE EXPERIENCED REDNESS AND ITCHING FOR FEW DAYS. SHE STILL ...
PATIENT RECEIVED PREVNAR 20 ON 1/28/25. SHE EXPERIENCED REDNESS AND ITCHING FOR FEW DAYS. SHE STILL HAS SOME REDNESS AROUND THE INJECTION SITE. I PROVIDED AN ICE PACK AND ADVISED HER TO TAKE BENADRYL FOR ITCHING IF NECESSARY
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| 2824598 | 38 | F | ID | 02/04/2025 |
TDAP |
SANOFI PASTEUR |
3CA17C1 |
No adverse event
No adverse event
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no adverse effects noted
no adverse effects noted
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